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New Draft Guidance Designed to Improve Pre-Submission Process

The FDA issued draft guidance this week designed to formalize and
improve the pre-submission process for medical device innovators. The
new program, called "Pre-Sub," is designed after a similar program for
drugmakers where regulators and industry meet and agree on specific
designs and goals for clinical studies in an effort to improve the
regulatory pathway.

"FDA's early feedback on studies can facilitate the development of a
quality premarket submission and help industry avoid regulatory hurdles
during the review process," said Christy Foreman, director of the Office
of Device Evaluation in CDRH.